# K161692: Diode Laser Therapy Machine

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Adss Development Co., Ltd.
- Decided: Nov 16, 2016 after 149 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K910422 (1992). 61 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141973: Diode Laser Hair Removal System, Beijing Anchorfree Technology Co., Ltd. (2014) Summary page 7.
- K123483: Diode Laser, Beijing Syntech Laser CO., LTD. (2013) Summary page 7.

## Most influential descendants
- K182924: Diode Laser Treatment System (2019), 2 descendants of its own
- K210033: Laser Treatment System, Model: NYX and Grace (2021), 1 descendant of its own
- K251339: Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) (2025), 0 descendants of its own
- K212793: Laser Treatment System, Model: Hera, Armo (2021), 0 descendants of its own
- K191970: Diode Laser Hair Removal System (2020), 0 descendants of its own

## Indications for use
The Diode Laser Therapy Machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K161692
Methodology: https://510kreport.com/methodology